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U.S. Department of Health and Human Services

Class 2 Device Recall VARIANT thalassemia Short Program

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  Class 2 Device Recall VARIANT thalassemia Short Program see related information
Date Initiated by Firm March 18, 2008
Date Posted September 11, 2008
Recall Status1 Terminated 3 on November 10, 2009
Recall Number Z-1588-2008
Recall Event ID 47421
510(K)Number K924122  
Product Classification Hematology Kits and Packages - Product Code JPD
Product VARIANT ¿-thalassemia Short Program Hemoglobin Testing System, Model Number 270-0019 (250 tests), with ¿-thalassemia ROM card lot PA 62600, PIN 2700104
Code Information Lot number 70080440
Recalling Firm/
Manufacturer		 Bio-Rad Laboratories Inc
4000 Alfred Nobel Dr
Hercules CA 94547-1803
For Additional Information Contact
510-724-7000
Manufacturer Reason
for Recall		 Some product ROM cards have an incorrect program loaded and are unable to be updated.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action The firm initiated its recall on March 18, 2008 by issuing a recall notice to customers and subsidiaries via e-mail. Not all VARIANT ¿-Thalassemia Short ROM Cards are affected. Inventory should be examined and quarantine the product subject to this Recall. Contact your regional Bio-Rad office for ROM Card replacement or if you have questions.
Quantity in Commerce 64 kits total
Distribution Product was distributed to 17 consignees and 7 subsidiaries Worldwide. Distribution included to states of CA, TX, WI, VA, UT, PA, TN, OH, FL, MA, OR, AR, IL, MD, CO, and NY, and countries of UK, Australia, Canada, France, Singapore, New Zealand, Italy.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JPD and Original Applicant = BIO-RAD
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